FDA-approved SLIT Tablets

Final approval and prescribing information pending, preliminary information from other countries and FDA advisory committee meetings below

Immunotherapy	Grastek (Alk-Abello/Merck)	Oralair (Stallergenes/Greer)	Ragwitek (Alk-Abello/Merck)
Allergen (dosage)	Timothy grass (2800 BAU/tablet)	Cocksfoot, Sweet vernal, Rye, Meadow, Timothy grass (100 and 300 IR/tablet) 100 IR = 3000 BAU 300 IR = 9000 BAU	Short Ragweed (12 Amb a 1 Units/tablet)
FDA-approved indications	≥5-65 years old Allergic rhinitis due to Timothy grass (or cross-reactive Northern grass)	≥10-65 years old Allergic rhinitis due to Northern grass pollen allergy	≥18-65 years old No efficacy data for >50 yo Allergic rhinitis due to Ragweed pollen allergy
Contraindications	Unstable or severe asthma Eosinophilic esophagitis Oral mucosal/dental lesions Fish allergy (contains fish gelatin) Gelatin or mannitol allergy History of severe local or systemic reaction with previous SLIT Beta blockers	Unstable or severe asthma Oral mucosal/dental lesions Milk allergy or lactose intolerance (contains lactose), mannitol allergy Beta blockers Use during pregnancy/nursing only if benefit justifies risk
Pregnancy/nursing	Category B Use during pregnancy only if clearly needed Unknown if excreted in human milk	Category B Use during pregnancy only if clearly needed Unknown if excreted in human milk
Dosing protocol	2 schedules: Pre/co-seasonal for symptom control only: start ≥12 weeks before pollen season and continue through season Year-round for 3 years for symptomatic treatment and sustained effectiveness in 4th year off of treatment No dose escalation (start at maintenance dose) First dose with 30 minute office observation Adult observation of children 30 minutes after each daily home dose Keep under tongue until dissolved (few seconds), avoid swallowing for 1 minute and eating/drinking for 5 minutes, wash hands after handling Hold doses during asthma exacerbations or while active/unhealed oral lesions are presents (e.g. dental extraction)	Pre/co-seasonal: start ≥16 weeks before pollen season and continue through season Dose escalation: Adults ≥18 yo: start at 300 IR (maintenance dose) Children 10-17 yo: 100 IR day 1, 200 IR day 2, 300 IR (maintenance dose) on day 3 and subsequent days First dose of each season with 30 minute office observation Adult observation of children 30 minutes after each daily home dose Keep tablet(s) (up to 2 at a time) under tongue for 1 minute, avoid swallowing for 1 minute and eating/drinking for 5 minutes, wash hands after handling Hold doses during asthma exacerbations or while active/unhealed oral lesions are presents (e.g. dental extraction)	Pre/co-seasonal: start ≥12 weeks (max 16 weeks) before pollen season and continue through season No dose escalation (start at maintenance dose) First dose with 30 minute office observation Keep under tongue until dissolved (few seconds), avoid swallowing for 1 minute and eating/drinking for 5 minutes, wash hands after handling
Dose adjustment for interruption	For interruption of any length, may resume at full dose at home	<7 days, resume at last dose at home >7 days, resume at last dose under observation in office	For interruption of any length, may resume at full dose at home
Adverse effects	Oropharyngeal pruritus (~25%) Throat irritation (~20%) Anaphylaxis rare but possible Local adverse effects are common and should be expected to occur within 30 minutes of dose on day 1-2	Oropharyngeal pruritus (~25%) Throat irritation (~22%) Anaphylaxis rare but possible	Oropharyngeal pruritus Throat irritation Anaphylaxis rare but possible
Epinephrine auto-injector required?	Yes	Yes	Yes

Grading SLIT Adverse Effects

SLIT local adverse effect grading.png

References

Grading local side effects of sublingual immunotherapy for respiratory allergy - JACI 2013.pdf